Lessons learned as a result of the COVID-19 pandemic are too plentiful to list. But one of the most important take-aways from the virus outbreak — and one we are again facing with the current amoxicillin shortage — is that America must reduce its reliance on other non-domestic supply for life-saving medical countermeasures (MCMs) like antibiotics, which harms both preparedness and our day-to-day healthcare delivery.
We may have "learned" this lesson, but we have failed to implement remedies accordingly. Americans are still forced to rely too heavily on foreign manufacturers for medicines and raw materials, leaving us vulnerable to the next pandemic and risking further damage to supply chain operations or worse, opening us to manipulation by those wishing us harm. We have focused for years on identifying necessary preparedness tools, but we haven't considered how many of those are simply not available domestically.
A vital element of our national and public health security framework, the Strategic National Stockpile (SNS), became a critical focus during COVID. Unknown to most Americans prior to March 2020, the SNS and its limited supply of assets were heavily scrutinized and frequently criticized for not being able to fully meet the demands of an unexpected outbreak. Congress has never adequately funded the SNS and we cannot rely on a fully domestic marketplace for emergency supplies. Even our regular healthcare market is too reliant on other countries for many of these products and the associated risks were magnified as China restricted exports during the initial stages of COVID.
Currently, China controls approximately 90% of the active pharmaceutical ingredients (API), as well as the raw materials used to make APIs, necessary to manufacture antibiotics. The cheaper cost of operating there — from minimal wages, loose regulatory requirements, substantial government subsidies, to government investment in production facilities — forced many American antibiotics manufacturers out of business or to relocate offshore, leaving us almost completely reliant on China for a vital class of drugs used to treat bacterial infections ranging from strep throat, ear infections, and bronchitis to life-threatening sepsis and pneumonia.
It’s worth noting that most fatalities resulting from the influenza pandemic of 1918 were caused by secondary bacterial infections that are treated with antibiotics. It is also important to understand that many bio-terror agents can be countered with common antibiotics that are no longer manufactured domestically. Should China or any other nation again decide to restrict pharmaceutical exports, the results could be catastrophic, with normally minor infections having major impacts. Our inability to domestically source vital antibiotics could ultimately be the way an enemy wins against the United States.
Quality control is also a concern. In 2008, doses of blood thinners containing tainted heparin sourced from a Chinese lab killed almost 100 people. Ten years later, 45 recalls were issued for generic blood pressure medications, also sourced from China, due to contamination with a cancer-causing chemical.
The U.S. Food and Drug Administration assures our national health security with planned and unplanned quality inspections in all manufacturing plants that supply the U.S. healthcare market. Americans deserve to know that foreign manufacturers are not subject to the same standards as those in the U.S. In China, FDA inspectors are required to give notice of inspections six months in advance, yet in the U.S. they can be conducted with little to no notice. During COVID, review of offshore facilities was greatly reduced.
Put simply, America cannot afford to maintain the status quo and continue to rely on an adversarial country for our most-needed drugs. It is long past time to take clear action to resolve this alarming vulnerability.
A company based in Bristol, TN, USAntibiotics, is the only remaining American manufacturer of two critical antibiotics, Amoxil and Augmentin. Bought out of bankruptcy last year by Jackson Healthcare, USAntibiotics is a prime example of a company that would be an invaluable partner as we begin to reclaim our pharmaceutical independence.
We’ve been caught off guard not once, but at least twice in recent years with unexpected, wide-spread disease outbreaks. This alone should have prompted greater domestic infrastructure investment and stronger public policy from the Congress. The current shortage of amoxicillin should have been anticipated, and the only way to prevent a similar event in the future is for the federal government to invest in the public-private partnerships key to implementing President Biden’s strategic preparedness plan and achieving his goals of increasing America’s manufacturing capabilities and competitive edge. Without these partnerships, American producers of these products will fail.
The critical drugs and other MCMs needed to protect all Americans should be made in America. We can and we must support efforts to boost our domestic manufacturing capabilities. Such an investment in our national security and a resilient, sustainable supply chain will yield immeasurable returns.
Greg Burel is former director of the Strategic National Stockpile (SNS) for the Department of Health and Human Services, Office of the Assistant Secretary for Preparedness and Response (ASPR).